Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT04693195
Eligibility Criteria:
Inclusion Criteria:
* Willing to participate and is capable of giving informed consent
* Clinically confirmed diagnosis of active AD with at least a 6-month history of AD
* Chronic pruritus related to AD for at least 3 months
* Moderate to severe itch associated with mild to moderate AD
* Female of childbearing potential must agree to use a highly effective contraceptive method during the study and until at least 4 weeks after the last study drug administration
Exclusion Criteria:
* History of skin disease or presence of skin condition that would interfere with the study assessments
* Clearly defined etiology for pruritus other than AD, including but not limited to: urticaria, psoriasis, or other non-atopic dermatologic conditions, hepatic or renal disease, psychogenic pruritus, drug reaction, uncontrolled hyperthyroidism, and infection
* Presence of any acute skin condition other than AD which may risk inducing a pruritus flare/worsening during the course of the study, including but not limited to: impetigo, active herpes simplex infection, or allergic contact dermatitis
* Subject is \>65 years of age and has developed pruritus at age of ≥50 years
* History of cancer or lymphoproliferative disease within 5 years with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix
* Known history of, or active, parasitic infection, including skin parasites such as scabies within 12 months prior to Screening
* Known history of chronic infectious disease (e.g. hepatitis B, hepatitis C, or human immunodeficiency virus \[HIV\])
* Known history of clinically significant drug or alcohol abuse in the last year
* Previous participation in a BLU-5937 trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04693195
Study Brief:
Protocol Section:
NCT04693195